Job Title

Manufacturing Operator II

Organization Name

InvaGen Pharmaceuticals, Inc.

Location

Central Islip, NY/Hauppauge, NY locations

Employment Type

Full Time

Salary Range

(Base/salary)

$ 18/hr - $20/hr

Benefits

In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance - medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) - vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid and unpaid family leave, employee discounts, and other benefits.

Work Hours/ Shift/ Remote

Must be willing and able to work any assigned shift ranging from first, second, or third shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs.

Responsibilities/ Accountabilities

• Must be willing to work in a pharmaceutical manufacturing setting.
• Must be able to know how to operate pharmaceutical production machinery independently and thoroughly complete required documentation (legible writing, accurate reporting, maintain and file, etc.)
• Execute procedures for manufacturing processes in accordance with batch manufacturing record (BMR) and Standard Operating Procedures (SOP) requirements.
• Perform machine changeovers, cleaning and set up as per SOPs. Ensure the proper area & equipment cleanliness and setup in stipulated time.
• Prepare a room and equipment for line clearance, replace room filters, Ensure verification and calibration of balance/scale and check pressure differential for the rooms.
• Ensure line clearance before initiating manufacturing activities in each area.
• Receive/transfer material from/to dispensing/manufacturing storage and check dispensed materials/final mix blend/compressed tablets and labeling as per BMR.
• Wear appropriate personal protective equipment (PPE) as stated in the SOP/BMR before initiating the process.
• Able to operate applicable equipment independently as per area of operation.
• Ensure adherence to quality standards during all stages of the manufacturing process.
• Complete manufacturing documents on time, ensuring accuracy and completeness.
• Responsible for training on all relevant SOPs and always maintain compliance with related SOPs and current Good Manufacturing Practices (cGMP) in the manufacturing process.
• Perform duties through the proper, safe use of equipment, according to Health & Safety procedures and Equipment Manuals.
• Flexible to work extended hours, to achieve manufacturing schedule when needed.
• Maintain discipline and comply with company policies and procedures.
• Perform entire duties as communicated time to time by department management/designee.
• Participate in safety related programs and or safety teams as needed.
• Enforce and follow safety regulations and ensure the working area is clean.
• Adhere to CIPLA's Safety, Health, and Environmental policies.
• Must be able to work under general supervision and able to work independently and in a team environment.
• Must be able to exercise appropriate professional judgment on matters of significance.
• Other duties assigned as required by Manufacturing Management.

Education Qualifications

• High School Diploma (or equivalent experience)

Experience

• Three (3) to six (6) years of direct work experience in pharmaceutical manufacturing. Preference will be given to candidates with experience in generic pharmaceutical manufacturing.

Skills/ Competencies

• Must have legible handwriting, and the ability to perform accurate documentation.
• Understanding of granulation, compression, coating, and encapsulation machines.
• Capable of conducting troubleshooting, investigations and root cause identification and analysis.
• Able to prioritize, plan and work under tight schedules and deadlines.
• Must possess strong documentation and technical writing skills and be able to apply relevant scientific principles and practices.
• Must communicate clearly and concisely across levels, both orally and in written.
• Strong command over written and verbal English is required.

Physical Requirements

• Should not have any restriction to work with powder containing active pharmaceutical ingredients.
• This position requires the ability to do heavy lifting / bending frequently.
• Long periods of standing up/walking during the working hours; ability to ascend/descend ladders; and able to lift to 35 pounds.
• Must be able to move pallets/equipment weighing about 200 - 300 kgs using suitable moving equipment like pallet jacks.